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Overview

NOTE: The information in this summary is no longer being updated and is provided for reference purposes only.

This cancer information summary provides an overview of the use of Cancell/Cantron/Protocel as a treatment in people with cancer. The discussion in the summary is limited to Cancell/Cantron/Protocel as it was originally conceived; the "vibrationally tuned" distilled water also distributed under the name Cancell will not be discussed.

This summary contains the following key information:

Cancell/Cantron/Protocel has been promoted by its manufacturers as an effective therapy for cancer and a number of other diseases.

Cancell/Cantron/Protocel is a mixture of common chemicals, none of which is known to be effective in treating any type of cancer.

No animal study or human study of Cancell/Cantron/Protocel has been published in a peer-reviewed scientific journal to show that it is safe or effective in treating cancer.

Cancell/Cantron/Protocel is not approved by the FDA for use in the United States as a treatment for a disease. There is a permanent injunction against distribution.

Many of the medical and scientific terms used in the summary are hypertext linked (at first use in each section) to the NCI Dictionary of Cancer Terms, which is oriented toward nonexperts. When a linked term is clicked, a definition will appear in a separate window.

Reference citations in some PDQ cancer information summaries may include links to external websites that are operated by individuals or organizations for the purpose of marketing or advocating the use of specific treatments or products. These reference citations are included for informational purposes only. Their inclusion should not be viewed as an endorsement of the content of the websites, or of any treatment or product, by the PDQ Integrative, Alternative, and Complementary Therapies Editorial Board or the National Cancer Institute.

General Information

Cancell/Cantron/Protocel, also known by the names Sheridan's Formula, Jim's Juice, JS-114, JS-101, 126-F, and the "Cancell-like" products Cantron and Protocel, is a liquid that has been produced in various forms principally by two manufacturers since the late 1930s.[1,2,3] It has been promoted as an effective therapy for cancer and a wide range of other diseases including AIDS, collagen disease, lupus, scleroderma, cystic fibrosis, multiple sclerosis, adult-onset diabetes mellitus, emphysema, Parkinson disease, hemophilia, hypotension, hypertension, and some forms of epilepsy and mental illness.[1,3]

The exact composition of Cancell/Cantron/Protocel is unknown. The U.S. Food and Drug Administration (FDA) has listed the components as inositol, nitric acid, sodium sulfite, potassium hydroxide, sulfuric acid, and catechol.[1,2] The original manufacturer also identified "crocinic acid" as a component;[1] however, information about the nature and origin of this chemical has not been provided, and it does not appear to be a known compound. An independent analysis of one formulation of Cancell/Cantron/Protocel found 12 different compounds, none of which is known to be effective in treating any form of cancer.[1]

Before researchers can conduct clinical drug research in the United States, they must file an Investigational New Drug (IND) application with the FDA. Entelev, which is the original name of the mixture, was assigned an IND number (IND #20258) by the FDA in 1982.[4] The IND currently remains inactive because information about the product's composition and studies showing its therapeutic effectiveness in animals have not been provided to the FDA.[1] In 1989, the FDA was granted a permanent injunction against both principal manufacturers of Cancell/Cantron/Protocel prohibiting them or their agents from distributing the mixture, which was judged an unapproved new drug.

Cancell/Cantron/Protocel has been administered orally, rectally, and topically.[1] Topical skin application is accomplished by dampening a cotton pad with the liquid and taping the moistened pad to the wrist or the ball of the foot after first treating the area with dimethyl sulfoxide. Cancer patients have also been advised to take bromelain, which is a digestive aid, and to avoid high intakes of vitamins C and E while undergoing treatment with Cancell/Cantron/Protocel.[1,3]

U.S. District Court for the Eastern District of Michigan: Complaint for Permanent Injunction: United States of America, Plaintiff, v. James V. Sheridan and Edmund J. Sopcak, Defendants. 21st February, 1989.

History

Cancell/Cantron/Protocel was developed in the 1950s by a chemist who called it Entelev and provided it free of charge to patients with terminal cancer.[1,2] In 1984, production was taken over by a second manufacturer who distributed the mixture free of charge under the trademarked name Cancell to individuals with cancer, AIDS, and other conditions.[1,2]

The two principal manufacturers of Cancell/Cantron/Protocel have offered somewhat different explanations for cancer development, but their theories about how the mixture works are quite similar. According to the original manufacturer, human cells can be normal, cancerous, or primitive.[1] Each of these cellular forms is distinguished by the degree of oxygen utilization in cellular metabolism. Normal cells use aerobic metabolism (glycolysis plus additional biochemical reactions that require oxygen) to produce the energy needed for growth and maintenance. Primitive cells only use glycolysis, which is a much less efficient way to produce energy. It was proposed that normal cells become cancerous when, in response to certain damaging conditions such as chronic energy stress (a demand for energy greater than the cell's ability to produce it), they reach a critical point and begin to rely mainly on glycolysis to produce energy. According to this theory, cancerous cells still maintain many of the features of normal cells and cannot be recognized by the body as foreign. According to the original manufacturer, Cancell/Cantron/Protocel causes cancer cells to become completely primitive, i.e., their residual aerobic metabolism is inhibited and they produce energy solely by glycolysis. The resulting primitive cells are then seen by the body as foreign and destroyed. While the aerobic metabolism of normal cells is also inhibited by Cancell/Cantron/Protocel, they are too far removed from the critical point to become cancerous or completely primitive.[1]

The second manufacturer suggested that a bacterium called Progenitor cryptocides is involved in cancer development.[1] According to this theory, P. cryptocides becomes activated in individuals whose bodies are damaged by an improper diet. Once activated, this bacterium helps cause damaged normal cells to shift their energy production from aerobic metabolism to glycolysis. When the demand for energy exceeds the damaged normal cell's ability to produce it, the cell mutates and becomes cancerous. Once again, Cancell/Cantron/Protocel forces cancerous cells into a completely primitive state where they self-digest and are replaced by normal cells. The waste material produced by this self-digestion process is discarded by the body in a variety of ways: in urine, stool, vaginal discharge, or perspiration; it may also be vomited or coughed up.[1]

The idea that cancer cells show increased levels of glycolysis compared with normal cells is widely accepted, but this change in metabolism is not believed to be a fundamental cause of cancer development.[3,4,5] In addition, there is no scientific evidence that Cancell/Cantron/Protocel or any of its components can cause cells to produce energy solely by glycolysis or is able to treat cancer effectively.[1,6] Furthermore, there is no evidence to date to support the existence of the bacterium P. cryptocides.[7]

Laboratory / Animal / Preclinical Studies

In 1978 and 1980, the National Cancer Institute (NCI) tested Cancell/Cantron/Protocel in animal studies and determined that the mixture lacked substantial antitumor activity.[1]

In 1990 and 1991, samples of Cancell/Cantron/Protocel were evaluated in NCI's in vitro NCI-60 DTP Human Tumor Cell Line Screen. In the screen, the cell lines are grown in artificial media under conditions that do not truly mimic the in vivo situation in animals or humans. The important information used in assessing a drug's effectiveness in the NCI in vitro screen includes drug concentrations necessary to achieve the following:

50% inhibition of cell growth (GI50; the concentration needed to reduce the growth of treated cells to half that of untreated [i.e., control] cells).

The log10 values for GI50, TGI, and LC50 for the 60 cell lines are available online.

The variations in log10 values for GI50 are 0.4 to 1.8 (mean = 1.15), equivalent to concentrations of 2.5 to 63 μg /mL (mean = 14); the variations in log10 values for TGI are 1.0 to 2.5 (mean = 1.62), equivalent to 10 to 320 μg/mL (mean = 41); and the variations in log10 values for LC50 are 1.6 to 3.9 (mean = 3.17), equivalent to 39 to 7,943 μg/mL (mean = 1,479).

Cancell/Cantron/Protocel Tumor Cell Line Screen Results

Parameter Measured

60 Cell-line Range (μg/mL)

Mean (μg/mL)

50% growth inhibition (GI50)

2.5–63

14

Total growth inhibition (TGI)

10–320

41

Concentration for 50% lethality (LC50)

39–7,943

1,479

Maximum theoretical humanplasmaconcentration (for comparison)

—

29 (calculated)

Based on the manufacturer's recommended doses of a marketed brand of Cancell/Cantron/Protocel it has been calculated that under idealized conditions of absolutely no loss of the constituents after administration to a patient (i.e., 100% bioavailability, meaning no loss due to degradation, absorption in the body, or rapid excretion—an unlikely situation), the maximum concentration that could be achieved in the plasma of an average 154-lb male is 29 μg/mL (antilog of 1.46). Thus, under these highly idealized conditions Cancell/Cantron/Protocel may exhibit some mild inhibitory effect on the growth of some cancer cells, but it would not be expected to inhibit their growth completely or to kill them. There is little evidence that any of the constituents of Cancell/Cantron/Protocel would be available in the bloodstream of a patient.

Activity was seen in two-thirds of the cell lines, though at levels that would be roughly 275 times higher than the theoretical maximum concentration achievable in serum. Therefore, the in vitro effects are likely due to nonspecific effects of changes in salt concentration. Furthermore, cells in the NCI Tumor Cell Line Screen are grown in artificial media under conditions that do not truly mimic the in vivo situation in animals or humans, and results obtained with the screen may not accurately reflect possible effects in humans. To place the findings for Cancell/Cantron/Protocel in perspective, any conventional drug exhibiting this low level of in vitro activity in the NCI human cancer cell line screen would normally not be investigated further by NCI.

The principal manufacturers of Cancell/Cantron/Protocel have stated that they have performed numerous animal experiments with the mixture involving tens of thousands of mice.[1,2] Results of these experiments, however, have not been published in peer-reviewed scientific journals and no information beyond stating that some of the experiments tested the toxicity of Cancell/Cantron/Protocel has been provided.

Human / Clinical Studies

The principal manufacturers of Cancell/Cantron/Protocel have stated that the mixture has been used by thousands of patients and that it is safe and effective in treating 50% to 80% of cancers.[1,2] The degree of effectiveness is said to vary with the type of malignancy. These findings, however, have not been published in peer-reviewed scientific journals and only testimonials and anecdotal reports have been provided. No clinical trials of Cancell/Cantron/Protocel have been reported.

Adverse Effects

The reported side effects of Cancell/Cantron/Protocel include temporary, moderate fatigue during the first few weeks of treatment and nausea.[1,2] One patient who exceeded the manufacturer's dose recommendations experienced diarrhea for a few hours but was reported to be fine the next day.[2]

Summary of the Evidence for Cancell / Cantron / Protocel

To assist readers in evaluating the results of human studies of integrative, alternative, and complementary therapies for cancer, the strength of the evidence (i.e., the levels of evidence) associated with each type of treatment is provided whenever possible. To qualify for a level of evidence analysis, a study must:

Be published in a peer-reviewed scientific journal.

Report on a therapeutic outcome or outcomes, such as tumor response, improvement in survival, or measured improvement in quality of life.

Describe clinical findings in sufficient detail that a meaningful evaluation can be made.

No levels of evidence analysis could be performed for Cancell/Cantron/Protocel because no study of its use in humans has been published in a peer-reviewed scientific journal. For additional information about levels of evidence analysis, refer to Levels of Evidence for Human Studies of Integrative, Alternative, and Complementary Therapies.

Changes to This Summary (04 / 21 / 2016)

The PDQ cancer information summaries are reviewed regularly and updated as new information becomes available. This section describes the latest changes made to this summary as of the date above.

Editorial changes were made to this summary.

This summary is written and maintained by the PDQ Integrative, Alternative, and Complementary Therapies Editorial Board, which is editorially independent of NCI. The summary reflects an independent review of the literature and does not represent a policy statement of NCI or NIH. More information about summary policies and the role of the PDQ Editorial Boards in maintaining the PDQ summaries can be found on the About This PDQ Summary and PDQ® - NCI's Comprehensive Cancer Database pages.

About This PDQ Summary

Purpose of This Summary

This PDQ cancer information summary for health professionals provides comprehensive, peer-reviewed, evidence-based information about the use of Cancell/Cantron/Protocel in the treatment of people with cancer in situ. It is intended as a resource to inform and assist clinicians who care for cancer patients. It does not provide formal guidelines or recommendations for making health care decisions.

Reviewers and Updates

This summary is reviewed regularly and updated as necessary by the PDQ Integrative, Alternative, and Complementary Therapies Editorial Board, which is editorially independent of the National Cancer Institute (NCI). The summary reflects an independent review of the literature and does not represent a policy statement of NCI or the National Institutes of Health (NIH).

Board members review recently published articles each month to determine whether an article should:

be discussed at a meeting,

be cited with text, or

replace or update an existing article that is already cited.

Changes to the summaries are made through a consensus process in which Board members evaluate the strength of the evidence in the published articles and determine how the article should be included in the summary.

The lead reviewer for Cancell/Cantron/Protocel is:

Jeffrey D. White, MD (National Cancer Institute)

Any comments or questions about the summary content should be submitted to Cancer.gov through the NCI website's Email Us. Do not contact the individual Board Members with questions or comments about the summaries. Board members will not respond to individual inquiries.

Levels of Evidence

Some of the reference citations in this summary are accompanied by a level-of-evidence designation. These designations are intended to help readers assess the strength of the evidence supporting the use of specific interventions or approaches. The PDQ Integrative, Alternative, and Complementary Therapies Editorial Board uses a formal evidence ranking system in developing its level-of-evidence designations.

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